FYC

Product Code: FYC


Products Classified as FYC

2817Gown, Isolation, SurgicalSurgical Apparel.

Total Product Life Cycle (TPLC) Devices

2817Gown, Isolation, SurgicalSurgical Apparel.

FDA Consensus Standards

Gown, Isolation, Surgical [32348]21 CFR §878.4040 🔎
Gown, Isolation, Surgical [36974]21 CFR §878.4040 🔎
Gown, Isolation, Surgical [32435]21 CFR §878.4040 🔎

Pre-market Notifications for FYC

K210131ComfortGuard Surgical Isolation GownGRI-Alleset, Inc
K203415Surgical Isolation GownYanbian Pacific Textile Co., LTD
K202310Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full BackWildcat PPE, LLC
K190306AMD Ritmed AssureWear VersaGownAMD Medicom Inc.
K182830Cardinal HealthTM Poly-Coated Open-Back Protective GownCardinal Health 200, LLC
K171535SURGICAL ISOLATION GOWNJingzhou Haixin Green Cross Medical Products Co., Ltd
K160471Medline Non-Surgical Isolation Gown-MEDLINE INDUSTRIES, INC.
K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)PRIMED MEDICAL PRODUCTS INC.
K160337Safecare Open Back Protective Gowns And ValueCare Open Back Protective GownsBAM CORPORATION LIMITED
K160339Cardinal Health Isolation GownCardinal Health 200, LLC
K982369CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNSALLEGIANCE HEALTHCARE CORP.
K972410IMPERVIOUS ISOLATION GOWNKENTRON HEALTH CARE, INC.
K971917KENTRON'S ISOLATION GOWNKENTRON HEALTH CARE, INC.
K971702FAR-EAST BARRIER GOWNSFAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
K970814NON-STERILE ISOLATION GOWNAMERICAN SEAL CO.

Global Unique Device Identification Database

20813360023046Gown, Isolation, Surgical
00812564039491Gown, Isolation, Surgical
00812564039323Gown, Isolation, Surgical
00812564035981Gown, Isolation, Surgical
00812564033420Gown, Isolation, Surgical
00812564033413Gown, Isolation, Surgical
00812564033383Gown, Isolation, Surgical
00812564032713Gown, Isolation, Surgical
00812564032195Gown, Isolation, Surgical
00812564032034Gown, Isolation, Surgical
00812564031945Gown, Isolation, Surgical
00812564031938Gown, Isolation, Surgical
00812564031921Gown, Isolation, Surgical
10818566010930Gown, Isolation, Surgical
10818566010923Gown, Isolation, Surgical

Maude Adverse Events

HALYARDO&M HALYARD, INC.2019-09-18
ACMF CARDIO PACK BLUE 2KIMBERLY-CLARK HEALTH CARE2014-07-11
COVER GOWN, YELLOWCARDINAL HEALTH2014-03-10
*GOWN, ISOLATIONKIMBERLY CLARK2013-07-16
*GOWN, ISOLATIONKIMBERLY-CLARK2013-04-25
*GOWN, ISOLATIONKIMBERLY-CLARK2013-04-24
*GOWN, ISOLATIONKIMBERLY-CLARK2013-04-24
*GOWN, ISOLATIONKIMBERLY-CLARK2013-04-24
*GOWN, ISOLATIONKIMBERLY CLARK2013-04-11
UNKPERSONAL PROTECTION GOWNBUSSE HOSPITAL DISPOSABLES2013-03-18
ISOLATION GOWNKIMBERLY-CLARK2013-03-05
ISOLATION GOWNKIMBERLY-CLARK CORPORATION2012-12-18
CONVERTORS YELLOW IMPERVIOUS ISOLATION GOWN W/KNIT CUFF, FULL BACK, UNIVERSALCARDINAL HEALTH2010-05-12
IMPERV. ISOLATION GOWN W/THUMBHOOKS 30/CCARDINAL HEALTH2008-12-11
GOWN ISOLATION YELLOWCARDINAL HEALTH2007-04-11
GOWN, ISOLATION, IMPERVIOUS, YELLOW, XL,CARDINAL HEALTH2006-05-03
GOWN ISOLATION YELLOWCARDINAL HEALTH2004-10-15
ISOLATION GOWN W/THUMB LOOP*1997-07-28
MELCO ISOLATION GOWNSMELCO INC.1995-07-31
ISOLATION GOWNMELCO, INC.1995-05-18
GOWNSAFETEC OF AMERICAL, INC.1994-03-21

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